Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase

NCT ID: NCT02722980

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-01-31

Brief Summary

The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The intervention consists of capsules containing placebo.

Active

Capsules.

Group Type: ACTIVE_COMPARATOR

: Probiotic capsules

Intervention Type: DIETARY_SUPPLEMENT

The intervention consists of capsules containing probiotics.

Interventions

Placebo

The intervention consists of capsules containing placebo.

Intervention Type: DIETARY_SUPPLEMENT

: Probiotic capsules

The intervention consists of capsules containing probiotics.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

For inclusion in the study, subjects must fulfil the following criteria:

1. Willing and able to give written informed consent for participation in the study.

2. Healthy women in early post-menopausal phase (at least two [2] years but a maximum of 12 years since the last menstruation and at least one [1] year since the last intake of hormone replacement therapy).

3. BMI ≥ 18 and ≤ 30 at screening.

4. BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.

5. Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.

6. Ability to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria

1. Relevant history of >1 previous fracture after 50 years of age, as judged by the Investigator.

2. T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.

3. History of metabolic bone disease.

4. Unstable weight (± five [5] kg) during the last six (6) months.

5. History of hyperthyroidism or unstable hypothyroidism.

6. Diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease (IBD), celiac disease or diabetes.

7. Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.

8. Gastric bypass surgery performed.

9. History of immunodeficiency or immunosuppressive treatment.

10. Chronic or acute diarrheal disease.

11. Recently diagnosed malignancy (within the last five [5] years).

12. Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.

13. Per-oral use of corticosteroids.

14. Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.

15. Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)

16. Use of any bone-formation stimulating therapy (currently or during the last 12 months).

17. Use of antibiotics during the last two (2) months.

18. Frequent user of antibiotics (>2 courses during the last 12 months) due to inter-current infection episodes.

19. Smoking or use of nicotine-containing products (currently or during the last six [6] months).

20. History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator.

21. Consumption of alcohol within 24 hours prior to the Baseline Visit.

22. Participation in any other clinical interventional study during the last three (3) months.

23. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study

24. Known hypersensitivity to any of the ingredients in the IP or the placebo (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).

25. Blood or plasma donation within three (3) months prior to baseline.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Probi AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Curiac

Role: PRINCIPAL_INVESTIGATOR

Gothenburg

Locations

Gothenburg, , Sweden

Uppsala, , Sweden

Countries

Sweden

References

Jansson PA, Curiac D, Lazou Ahren I, Hansson F, Martinsson Niskanen T, Sjogren K, Ohlsson C. Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2019 Nov;1(3):e154-e162. doi: 10.1016/S2665-9913(19)30068-2. Epub 2019 Oct 23.

Reference Type: DERIVED

PMID: 38229392 (View on PubMed)

Other Identifiers

ProBone16

Identifier Type: -

Identifier Source: org_study_id